U.S. patent number 10,456,533 [Application Number 14/306,925] was granted by the patent office on 2019-10-29 for methods and devices for protecting catheter tips and stereotactic fixtures for microcatheters.
This patent grant is currently assigned to Alcyone Lifesciences, Inc.. The grantee listed for this patent is ALCYONE LIFESCIENCES, INC.. Invention is credited to P J Anand, Deep Arjun Singh.
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United States Patent |
10,456,533 |
Singh , et al. |
October 29, 2019 |
Methods and devices for protecting catheter tips and stereotactic
fixtures for microcatheters
Abstract
Methods and devices are disclosed herein that generally provide
protection for devices (e.g., microcatheters) having small tips.
Methods and devices are also disclosed herein that generally
facilitate use of commercially-available stereotactic systems with
devices (e.g., microcatheters) having small tips.
Inventors: |
Singh; Deep Arjun (Allston,
MA), Anand; P J (Ayer, MA) |
Applicant: |
Name |
City |
State |
Country |
Type |
ALCYONE LIFESCIENCES, INC. |
Concord |
MA |
US |
|
|
Assignee: |
Alcyone Lifesciences, Inc.
(Lowell, MA)
|
Family
ID: |
52019843 |
Appl.
No.: |
14/306,925 |
Filed: |
June 17, 2014 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20140371711 A1 |
Dec 18, 2014 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61835905 |
Jun 17, 2013 |
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61984061 |
Apr 25, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
90/11 (20160201); A61M 5/46 (20130101); A61B
17/3496 (20130101); A61B 2090/034 (20160201) |
Current International
Class: |
A61M
5/46 (20060101); A61B 17/34 (20060101); A61B
90/00 (20160101); A61B 90/11 (20160101) |
Field of
Search: |
;606/108,130 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
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|
|
|
101123919 |
|
Feb 2008 |
|
CN |
|
101657189 |
|
Feb 2010 |
|
CN |
|
2 042 212 |
|
Apr 2009 |
|
EP |
|
2009-507531 |
|
Feb 2009 |
|
JP |
|
2009-526589 |
|
Jul 2009 |
|
JP |
|
2010-501233 |
|
Jan 2010 |
|
JP |
|
2011-212502 |
|
Oct 2011 |
|
JP |
|
95/05864 |
|
Mar 1995 |
|
WO |
|
97/00442 |
|
Jan 1997 |
|
WO |
|
97/17105 |
|
May 1997 |
|
WO |
|
97/40874 |
|
Nov 1997 |
|
WO |
|
97/48425 |
|
Dec 1997 |
|
WO |
|
98/52064 |
|
Nov 1998 |
|
WO |
|
99/52585 |
|
Oct 1999 |
|
WO |
|
00/51669 |
|
Sep 2000 |
|
WO |
|
02/068036 |
|
Sep 2002 |
|
WO |
|
02/085431 |
|
Oct 2002 |
|
WO |
|
2004/060465 |
|
Jul 2004 |
|
WO |
|
2006/015091 |
|
Feb 2006 |
|
WO |
|
2007/093778 |
|
Aug 2007 |
|
WO |
|
2007/104953 |
|
Sep 2007 |
|
WO |
|
2007/133545 |
|
Nov 2007 |
|
WO |
|
2008/100930 |
|
Aug 2008 |
|
WO |
|
2008/134509 |
|
Nov 2008 |
|
WO |
|
2010/006293 |
|
Jan 2010 |
|
WO |
|
2010/081072 |
|
Jul 2010 |
|
WO |
|
2011/098769 |
|
Aug 2011 |
|
WO |
|
2011/109735 |
|
Sep 2011 |
|
WO |
|
2012/145652 |
|
Oct 2012 |
|
WO |
|
2013/019830 |
|
Feb 2013 |
|
WO |
|
2014/016591 |
|
Jan 2014 |
|
WO |
|
Other References
Invitation to Pay Additonal Fees for Application No.
PCT/US2014/049031, dated Nov. 24, 2014 (2 pages). cited by
applicant .
International Search Report and Written Opinion for Application No.
PCT/2014/049031 dated Jan. 30, 2015 (16 pages). cited by applicant
.
Lewis et al., Design and characterization of a high-power
ultrasound driver with ultralow-output impedance. Rev Sci Instrum.
Nov. 2009;80(11):114704.1-114704.8. cited by applicant .
Burmeister et al.; Improved Ceramic-Based Multisite Microelectrode
for Rapid Measurements of L-Giutamate in the CNS; Journal of
Neuroscience Methods 119 (2002) 163-171; Elsevier Science B.V.
cited by applicant .
International Search Report and Written Opinion for Application No.
PCT/US2012/049100, dated Jan. 29, 2013. (12 pages). cited by
applicant .
International Search Report and Written Opinion for Application No.
PCT/US2013/076084 dated Mar. 11, 2014 (13 Pages). cited by
applicant .
International Search Report for International Application No.
PCT/US2011/027238, dated Nov. 15, 2011. cited by applicant .
Olbricht, William L. et al., Microfluidic Probes in the Treatment
of Brain-Related Diseases, Drug News and Perspectives, 2010,
23(8)--7 pages (Oct. 2010). cited by applicant .
Saltzman et al.; Building Drug Delivery Into Tissue Engineering;
Nature Reviews/Drug Discovery; 2002 Macmillan Magazines Ltd.; vol.
1; Mar. 2002; pp. 177-186. cited by applicant .
International Search Report and Written Opinion for Application No.
PCT/US2014/042726 dated Oct. 28, 2014 (13 Pages). cited by
applicant .
Extended European Search Report for Application No. 12819276.2,
dated Mar. 23, 2015 (7 pages). cited by applicant .
Extended European Search Report for Application No. 13865917.2,
dated Aug. 17, 2016 (6 pages). cited by applicant .
Extended European Search Report for Application No. 14814380.3,
dated Nov. 11, 2016. (7 pages). cited by applicant .
Chinese Office Action for Application No. 201280046268.8, dated May
27, 2015 (45 pages). cited by applicant .
Debinski, W., et al., "Convection-enhanced Delivery for the
Treatment of Brain Tumors," Expert Rev Neurother. Oct. 2009; 9(10):
1519-1527. cited by applicant .
Fiandaca, M., et al., "Use of Convection-Enhanced Delivery with
Liposomal Toxins in Neurooncology," Toxins 2011, 3 (4), 369-397.
cited by applicant .
Rapoport, S.I., "Osmotic opening of the blood-brain barrier:
principles, mechanism, and therapeutic applications," Cell. Mol.
Neurobiol. 20: 217-30 (2000). cited by applicant .
Extended European Search Report for Application No. 14831460.2,
dated Mar. 2, 2017 (7 pages). cited by applicant .
Japanese Office Action for Application No. 2015-549618, dated Sep.
5, 2017 (12 pages). cited by applicant .
Japanese Office Action for Application No. 2016-531883, dated Jun.
5, 2018 (10 pages). cited by applicant.
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Primary Examiner: Erezo; Darwin P
Assistant Examiner: Schwiker; Katherine H
Attorney, Agent or Firm: Nutter, McClennen & Fish
LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional Application
No. 61/835,905 filed on Jun. 17, 2013 and to U.S. Provisional
Application No. 61/984,061 filed on Apr. 25, 2014, each of which is
hereby incorporated herein by reference in its entirety.
Claims
The invention claimed is:
1. A method of inserting a catheter into a patient, comprising:
registering a stereotactic system to the patient; inserting the
catheter having a tip protection device disposed over a distal tip
thereof into a working channel of the stereotactic system until a
depth stop on the tip protection device prevents further insertion,
the tip protection device comprising an elongate body having a
central lumen extending longitudinally therethrough configured to
slidably receive the catheter, the tip protection device further
including a locking mechanism comprising a set screw configured to
intersect the central lumen, wherein the locking mechanism of the
tip protection device is engaged with a portion of the catheter in
the central lumen during insertion to hold the catheter in a fixed
longitudinal position with respect to the tip protection device
and, thereby, to prevent the catheter from advancing longitudinally
any of distally and proximally in the tip protection device;
releasing the locking mechanism of the tip protection and advancing
the catheter distally into the patient; and engaging a locking
mechanism of the stereotactic system with the tip protection device
by tightening a set screw of the stereotactic system such that the
set screw contacts an outer surface of the body of the tip
protection device while the catheter is located within the central
lumen of the tip protection device, thereby engaging the tip
protection device onto the catheter to maintain a fixed
longitudinal position between the catheter and the stereotactic
system.
2. The method of claim 1, further comprising delivering a
therapeutic agent through the catheter using convection-enhanced
delivery.
3. The method of claim 1, further comprising, before said releasing
and engaging, piercing a dura of the patient with a sharpened
distal tip of the tip protection device, removing the tip
protection device from the stereotactic system, snapping off the
sharpened distal tip of the tip protection device, and reinserting
the tip protection device through the stereotactic system.
4. The method of claim 1, further comprising inserting the tip
protection device through a central lumen of a guide tube mounted
in the stereotactic system such that a distal end of the tip
protection device is received within a proximal portion of the
central lumen of the guide tube.
5. The method of claim 4, wherein advancing the catheter comprises
advancing a distal tip of the catheter through a distal portion of
the central lumen of the guide tube, the distal portion of the
central lumen of the guide tube having a diameter that is less than
a diameter of the proximal portion of the central lumen of the
guide tube, such that at least a portion of the catheter is
disposed within the distal portion of the central lumen of the
guide tube.
6. The method of claim 4, further comprising inserting the guide
tube through a guide stop adapter and a guide block adapter mounted
in the stereotactic system.
7. The method of claim 1, further comprising, before said releasing
and engaging, piercing a tissue of the patient with a sharpened
distal tip of the tip protection device, and subsequently
separating the sharpened distal tip from the tip protection device
at a perforated snap portion.
8. A method of inserting a catheter into a patient, comprising:
registering a stereotactic system to the patient; inserting the
catheter having a tip protection device disposed over a distal tip
thereof into a working channel of the stereotactic system until a
depth stop on the tip protection device prevents further insertion;
releasing a locking mechanism of the tip protection device that
prevents the catheter from moving longitudinally any of distally
and proximally within the tip protection device, where the
releasing step includes releasing the locking mechanism by
loosening a set screw of the tip protection device thereby
laterally withdrawing the set screw from a central lumen of the tip
protection device in which the catheter is disposed such that the
catheter is free to move longitudinally with respect to the tip
protection device and the working channel, and advancing the
catheter distally into the patient; and engaging a locking
mechanism of the stereotactic system over the tip protection
device, thereby tightening the tip protection device onto the
catheter to fix a longitudinal position between the catheter, the
tip protection device, and the stereotactic system.
9. The method of claim 8, further comprising delivering a
therapeutic agent through the catheter using convection-enhanced
delivery.
10. The method of claim 8, further comprising, before said
releasing and engaging, piercing a dura of the patient with a
sharpened distal tip of the tip protection device, removing the tip
protection device from the stereotactic system, snapping off the
sharpened distal tip of the tip protection device, and reinserting
the tip protection device through the stereotactic system.
11. The method of claim 8, further comprising inserting the tip
protection device through a central lumen of a guide tube mounted
in the stereotactic system such that a distal end of the tip
protection device is received within a proximal portion of the
central lumen of the guide tube.
12. The method of claim 11, wherein advancing the catheter
comprises advancing a distal tip of the catheter through a distal
portion of the central lumen of the guide tube, the distal portion
of the central lumen of the guide tube having a diameter that is
less than a diameter of the proximal portion of the central lumen
of the guide tube, such that at least a portion of the catheter is
disposed within the distal portion of the central lumen of the
guide tube.
13. The method of claim 11, further comprising inserting the guide
tube through a guide stop adapter and a guide block adapter mounted
in the stereotactic system.
14. The method of claim 8, wherein the tip protection device
comprises an elongate body having a central lumen extending
longitudinally therethrough configured to slidably receive the
catheter, wherein the locking mechanism of the tip protection
device is engaged with a portion of the catheter in the central
lumen during insertion of the catheter into the stereotactic system
to hold the catheter in a fixed longitudinal position with respect
to the tip protection device.
15. The method of claim 8, further comprising, before said
releasing and engaging, piercing a tissue of the patient with a
sharpened distal tip of the tip protection device, and subsequently
separating the sharpened distal tip from the tip protection device
at a perforated snap portion.
16. A method of inserting a catheter into a patient, comprising:
registering a stereotactic system to the patient; inserting the
catheter having a tip protection device disposed over a distal tip
thereof into a working channel of the stereotactic system until a
depth stop on the tip protection device prevents further insertion,
the tip protection device comprising an elongate body having a
central lumen extending longitudinally therethrough configured to
slidably receive the catheter, the tip protection device further
including a locking mechanism comprising a set screw configured to
intersect the central lumen, wherein the locking mechanism of the
tip protection device is engaged with a portion of the catheter in
the central lumen during insertion to hold the catheter in a fixed
longitudinal position with respect to the tip protection device;
piercing a dura of the patient with a sharpened distal tip of the
tip protection device; removing the tip protection device from the
stereotactic system and snapping off the sharpened distal tip of
the tip protection device at a perforated snap portion; reinserting
the tip protection device through the stereotactic system;
releasing the locking mechanism of the tip protection device and
advancing the catheter distally into the patient; and engaging a
locking mechanism of the stereotactic system with the tip
protection device by tightening a set screw of the stereotactic
system such that the set screw contacts an outer surface of the
body of the tip protection device while the catheter is located
within the central lumen of the tip protection device, thereby
engaging the tip protection device onto the catheter to maintain a
fixed longitudinal position between the catheter and the
stereotactic system.
Description
FIELD
Methods and devices for protecting catheter tips and stereotactic
fixtures for microcatheters are disclosed herein.
BACKGROUND
In convection-enhanced delivery (CED), drugs are infused locally
into tissue through a needle, cannula, or microcatheter inserted
into the tissue. Transport of the infused material is dominated by
convection, which enhances drug penetration into the target tissue
compared with diffusion-mediated delivery or systemic delivery.
The devices used to perform CED, as well as devices used in several
other fields, can include a very small, thin tip (e.g., a
microfabricated tip). For example, as shown in FIG. 1, a
microcatheter 100 can include a catheter body 102 with a
microfabricated tip 104 at the distal end thereof. The tip can be
damaged or broken during handling and/or during a surgical
procedure. For example, the tip can either break during handling as
a user hits the catheter tip against an object, or the surgeon may
break the tip while inserting it in the brain through a
stereotactic system. Stereotactic systems generally have a lumen
with a small inside diameter (ID) to snugly fit the catheter. For
example, as shown in FIG. 2, an exemplary stereotactic system 200
has a small-diameter central lumen 202 extending therethrough. The
surgeon is required to "aim" the small catheter into the tight
lumen to get the catheter loaded into the stereotactic system.
Catheters with small tips may get damaged as the surgeon may hit
the tip against the stereotactic system while manually trying to
align the catheter to the small lumen. In addition, stereotactic
systems are generally sized for larger instruments and cannot
adequately support and protect catheters with small diameters or
small tips.
A need exists for methods and devices for protecting catheter tips
and stereotactic fixtures for microcatheters.
SUMMARY
Methods and devices are disclosed herein that generally provide
protection for devices (e.g., microcatheters) having small tips.
Methods and devices are also disclosed herein that generally
facilitate use of commercially-available stereotactic systems with
devices (e.g., microcatheters) having small tips.
In some embodiments, a tip protection device includes an elongate
body having a central lumen extending longitudinally therethrough,
the lumen being sized and configured to slidably receive a
catheter, and a locking mechanism configured to selectively
maintain the elongate body in a fixed longitudinal position
relative to a catheter inserted through the central lumen.
The locking mechanism can include a screw. The elongate body can
include an increased-diameter portion configured to act as a depth
stop when the elongate body is inserted through a lumen of a
stereotactic system. The elongate body can be formed from at least
one of silastic, poly-urethane, poly-ester, PTFE, E-PTFE, stainless
steel, polycarbonate, PVC, Delrin, aluminum, PEEK, plastic, metal,
and titanium. The elongate body can be fabricated using at least
one of extrusion, molding, and machining. The elongate body can
include a sharpened distal tip. The distal tip can be separable
from the elongate body along a perforated snap portion. The
elongate body can include a distal cylindrical portion having a
first diameter and a proximal cylindrical portion having a second
diameter that is greater than the first diameter. The central lumen
can have a diameter of about 0.5 mm to about 4.0 mm.
In some embodiments, a system includes a tip protection device
(e.g., of the type described above) and a depth stop comprising a
cylindrical body portion having a central lumen extending
longitudinally therethrough and a locking mechanism configured to
selectively engage a catheter inserted through the cylindrical body
portion.
In some embodiments, a system includes a tip protection device
(e.g., of the type described above) and a guide tube that includes
an elongate body having a central lumen extending longitudinally
therethrough, the central lumen including a proximal portion having
a first diameter and a distal portion having a second diameter that
is less than the first diameter, the proximal portion being sized
to receive a reduced diameter distal portion of the tip protection
device and the distal portion being sized to receive at least a
portion of a catheter inserted through the tip protection
device.
The elongate body of the guide tube can include a proximal portion
having an outside diameter which is greater than an outside
diameter of a distal portion of the elongate body of the guide
tube. A distal end of the guide tube can be tapered. The system can
include a guide stop adapter comprising a cylindrical disc having
an inside diameter sized to receive the distal portion of the guide
tube therethrough and an outside diameter sized to fit within a
guide stop of a stereotactic system, and a guide block adapter
comprising a cylindrical sleeve having an inside diameter sized to
receive the distal portion of the guide tube therethrough and an
outside diameter sized to fit within a guide block of a
stereotactic system. The guide tube can have a length sufficient to
span a distance between the guide block of the stereotactic system
and a skull of a patient to which the stereotactic system is
registered.
In some embodiments, a method of inserting a catheter into a
patient includes registering a stereotactic system to the patient,
inserting a catheter having a tip protection device disposed over a
distal tip thereof into a working channel of the stereotactic
system until a depth stop on the tip protection device prevents
further insertion, releasing a locking mechanism of the tip
protection device and advancing the catheter distally into the
patient, and engaging a locking mechanism of the stereotactic
system with the tip protection device, thereby engaging the tip
protection device with the catheter to maintain a fixed
longitudinal position between the catheter and the stereotactic
device.
The method can include delivering a therapeutic agent through the
catheter using convection-enhanced delivery. The method can
include, before said releasing and engaging, piercing the dura of
the patient with a sharpened distal tip of the tip protection
device, removing the tip protection device from the stereotactic
frame, snapping off the sharpened distal tip of the tip protection
device, and reinserting the tip protection device through the
stereotactic frame. The method can include inserting the tip
protection device through a central lumen of a guide tube mounted
in the stereotactic system such that a distal end of the tip
protection device is received within a proximal portion of the
central lumen of the guide tube. Advancing the catheter can include
advancing a distal tip of the catheter through a distal portion of
the central lumen of the guide tube, the distal portion of the
central lumen of the guide tube having a diameter that is less than
a diameter of the proximal portion of the central lumen of the
guide tube, such that at least a portion of the catheter is
disposed within the distal portion of the central lumen of the
guide tube. The method can include inserting the guide tube through
a guide stop adapter and a guide block adapter mounted in the
stereotactic system.
The present invention further provides devices, systems, and
methods as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be more fully understood from the following
detailed description taken in conjunction with the accompanying
drawings, in which:
FIG. 1 is a perspective view of an exemplary microcatheter;
FIG. 2 is a perspective view of an exemplary stereotactic
system;
FIG. 3 is a perspective view of an exemplary tip protector;
FIG. 4 is a perspective view of the tip protector of FIG. 3 shown
with the microcatheter of FIG. 1;
FIG. 5 is another perspective view of the tip protector of FIG. 3
shown with the microcatheter of FIG. 1;
FIG. 6 is another perspective view of the tip protector of FIG. 3
shown with the microcatheter of FIG. 1;
FIG. 7 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, and an exemplary stereotactic system;
FIG. 8 is another perspective view of the tip protector of FIG. 3,
the microcatheter of FIG. 1, and an exemplary stereotactic
system;
FIG. 9 is another perspective view of the tip protector of FIG. 3,
the microcatheter of FIG. 1, and an exemplary stereotactic
system;
FIG. 10 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, and an exemplary depth stop;
FIG. 11 is perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, the depth stop of FIG. 10, and an
exemplary stereotactic system;
FIG. 12 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, and another exemplary stereotactic
system;
FIG. 13 is a perspective view of an exemplary guide tube;
FIG. 14 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, the guide tube of FIG. 13, and another
exemplary stereotactic system;
FIG. 15 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, the depth stop of FIG. 10, and the guide
tube of FIG. 13;
FIG. 16 is another perspective view of the tip protector of FIG. 3,
the microcatheter of FIG. 1, the depth stop of FIG. 10, and the
guide tube of FIG. 13;
FIG. 17 is a perspective view of another exemplary stereotactic
system;
FIG. 18 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, the depth stop of FIG. 10, the guide tube
of FIG. 13, an exemplary guide stop adapter, and an exemplary guide
block adapter;
FIG. 19 is another perspective view of the tip protector of FIG. 3,
the microcatheter of FIG. 1, the depth stop of FIG. 10, the guide
tube of FIG. 13, and the guide stop and guide block adapters of
FIG. 18; and
FIG. 20 is a perspective view of the tip protector of FIG. 3, the
microcatheter of FIG. 1, the depth stop of FIG. 10, the guide tube
of FIG. 13, the guide stop and guide block adapters of FIG. 18, and
an exemplary stereotactic system.
DETAILED DESCRIPTION
Methods and devices are disclosed herein that generally provide
protection for devices (e.g., microcatheters) having small tips.
Methods and devices are also disclosed herein that generally
facilitate use of commercially-available stereotactic systems with
devices (e.g., microcatheters) having small tips.
Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the methods, systems, and devices disclosed
herein. One or more examples of these embodiments are illustrated
in the accompanying drawings. Those skilled in the art will
understand that the methods, systems, and devices specifically
described herein and illustrated in the accompanying drawings are
non-limiting exemplary embodiments and that the scope of the
present invention is defined solely by the claims. The features
illustrated or described in connection with one exemplary
embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included
within the scope of the present invention.
In some embodiments, a tip protector is provided in the form of a
sleeve. The sleeve can be formed by cutting a length of tubing or
using extrusion, molding, and/or machining processes. The sleeve
can include a central lumen extending longitudinally therethrough,
defined by a relatively thin wall. The sleeve can be slid over the
catheter (or similar small-tip device) to protect the catheter tip
from breakage or damage during handling or use. The tip protector
can be configured to sit over the catheter or other device such
that it covers and protects the micro-tip. The tip protector can be
secured on the catheter using a set-screw or a snap feature, or
other feature that can easily be un-deployed to slide the catheter
through the sleeve as needed. The tip protector can be packaged and
shipped with the catheter (e.g., with the protector pre-installed
over the tip of the catheter).
In use, the surgeon/user can align the catheter to the stereotactic
system using the sleeve as a reference. Once aligned, the tip
protector and catheter can be slid inside the stereotactic system
(the tip protector can be sized to fit existing systems). Once
inside the stereotactic system, the user can loosen the set-screw
on the tip protector to slide the catheter further into the brain
or other tissue. The proximal end of the tip protector can have a
large outside diameter (OD) stop or collar that does not allow it
to slide inside the stereotactic system as the catheter is being
inserted into the brain. Once the catheter is inserted into the
brain, the stereotactic system set-screw can be tightened over the
tip-protector sleeve (due to the thin wall) onto the catheter to
fix it in place and prevent the catheter from sliding. The tip
protector can be MRI compatible so that it does not interfere with
MR imaging.
FIG. 3 illustrates an exemplary embodiment of a tip protector 300
having a set screw and a large diameter stop portion. As shown, the
tip protector 300 includes an elongate sleeve 302. The distal
portion 320d of the sleeve 302 has an outside diameter which is
less than the outside diameter of the proximal portion 302p of the
sleeve. The outside diameter of the sleeve 302 can be curved,
ramped, stepped, or tapered at the junction of the proximal and
distal portions to provide a transition or shoulder 304. This
transition 304 can act as a shoulder or stop surface to limit the
degree to which the tip protector 300 can be advanced distally
through a cylindrical opening, such as the opening of a
stereotactic system. A central cylindrical lumen 306 extends
through the tip protector 300 from a proximal end of the sleeve 302
to a distal end of the sleeve. The lumen 306 is sized and
configured to receive at least a portion of a catheter
therethrough. The tip protector 300 also includes a set screw 308
threadably mounted in a channel 310 which extends perpendicular to
the central lumen 306. Rotation of the set screw 308 in a first
direction can be effective to advance the set screw within the
channel 310 such that it extends into the central lumen 306 and
engages a catheter or other instrument inserted therethrough.
Rotation of the set screw 308 in a second, opposite direction can
be effective to withdraw the set screw within the channel 310 such
that it does not extend into the central lumen 306 and does not
engage a catheter or other instrument inserted therethrough.
The tip protector 300 is shown in FIG. 4 with an exemplary
embodiment of a microcatheter 100 for convection-enhanced delivery.
It will be appreciated that any of a variety of microcatheters or
other instruments can be used with the tip protector. Exemplary
microcatheter devices are disclosed in the following references,
the entire contents of each of which are hereby incorporated by
reference herein: U.S. Publication No. 2013/0035560 entitled
MULTI-DIRECTIONAL MICROFLUIDIC DRUG DELIVERY DEVICE; U.S.
Publication No. 2013/0035574 entitled MICROFLUIDIC DRUG DELIVERY
DEVICES WITH VENTURI EFFECT; U.S. Publication No. 2013/0035660
entitled MULTIDIRECTIONAL MICROFLUIDIC DRUG DELIVERY DEVICES WITH
CONFORMABLE BALLOONS; U.S. application Ser. No. 14/132,762 entitled
SYSTEMS AND METHODS FOR REDUCING OR PREVENTING BACKFLOW IN A
DELIVERY SYSTEM; U.S. Publication No. 2010/0098767 entitled
CONVECTION ENHANCED DELIVERY APPARATUS, METHOD, AND APPLICATION;
and U.S. Publication No. 2013/0046230 entitled ULTRASOUND-ASSISTED
CONVECTION ENHANCED DELIVERY OF COMPOUNDS IN VIVO WITH A TRANSDUCER
CANNULA ASSEMBLY.
As shown in FIG. 5, the microcatheter 100 can be inserted through
the central lumen 306 of the tip protector 300. The set screw 308
can be tightened to secure the tip protector 300 to the
microcatheter 100 and prevent longitudinal translation of the tip
protector relative to the microcatheter. The microcatheter 100 can
also be positioned such that the tip 104 of the microcatheter
protrudes from a distal end of the tip protector 300, as shown in
FIG. 6. This relative positioning of the tip protector 300 and the
microcatheter 100 would typically be used only after the
microcatheter is inserted into the stereotactic system, although
the user may wish to slide the tip 104 out of the tip protector
before insertion to confirm fluid flow during priming, etc., and
then retract the tip back into the tip protector before inserting
the catheter through the stereotactic system.
The tip protector can be used with any of a variety of stereotactic
systems. For example, as shown in FIGS. 7-9, the tip protector 300
can be used with a stereotactic system 200 of the type available
from MEDTRONIC, INC. under the NAVIGUS brand. The illustrated
stereotactic system 200 includes a base 204 with a locking ring 206
and a stem 208 that can be positioned at various angles with
respect to the base. The stem 208 includes a set screw 210 to
secure a device inserted through an inner lumen 202 of the stem. In
use, the base 204 is installed over a portion of the patient (e.g.,
a burr hole formed in the patient's skull).
As shown in FIG. 7, the microcatheter 100 can be aligned to the
small hole 202 in the stem 208 without damaging the catheter tip by
using the tip protector 300 as a visual and contact reference. The
outside diameter of the distal portion 302d of the tip protector
300 can be sized to substantially match the inside diameter of the
central lumen 202 of the stem 208 such that the tip protector fits
snugly within the stereotactic system 200, as shown in FIG. 8. As
shown in FIG. 9, the tip protector 300 can be advanced distally
within the stem 208 until the shoulder portion 304 of the tip
protector engages the proximal end of the stem and prevents further
insertion. The large diameter stop portion 302p on the tip
protector 300 can thus prevent the tip protector from being
advanced too far through the stereotactic system 200. The distal
portion 302d of the tip protector 300 can have a length that
substantially corresponds to the length of the stem 208, such that
the distal end of the tip protector is aligned with the distal end
of the stereotactic system 200 when the tip protector is inserted
up to the shoulder portion 304.
Once the tip protector 300 is inserted through the stem 208, the
set screw 308 of the tip protector can be loosened to allow the
microcatheter 100 to be translated longitudinally relative to the
tip protector and the stem, such that the catheter tip can be
advanced distally into the patient or retracted proximally from the
patient. The set screw 210 on the stem 208 can be tightened over
the tip protector 300 to secure the catheter 100 and the tip
protector with respect to the stem.
The terminal distal end of the tip protector 300 can also be made
to be sharp and, when the tip protector is fully-advanced into the
stereotactic system 200, the distal tip of the tip protector can
extend into the skull and past the dura to ensure the dura and
corresponding anatomies are pierced and will not interfere with the
catheter micro-tip 104 during insertion. For example, the distal
tip of the tip protector 300 can be pointed or otherwise sharpened
and can extend a few millimeters beyond the skull when inserted
through the stereotactic system 200. The length of the tip
protector 300 can thus be selected based on the stereotactic system
with which it will be used to achieve the desired degree of
protrusion. In an exemplary method of use, the catheter 100 and
that elongated, sharp-tipped protector 300 can be inserted through
the stereotactic system 200 such that the distal tip of the tip
protector extends through the skull and a few millimeters past the
dura, thereby opening, tearing, and/or piercing the dura. The
catheter 100 and the tip protector 300 can then be removed and the
sharp tip of the tip protector can be broken or snapped off (e.g.,
along a perforated snap section or frangible portion) to expose the
lumen 306 of the tip protector. The tip protector 300 and the
catheter 100 can then be re-inserted and used as described
above.
As shown in FIG. 10, a depth stop 312 can be included for setting
the desired insertion depth of the microcatheter 100 and preventing
over-insertion. The illustrated depth stop 312 includes a collar
314 that can be longitudinally slidable with respect to the
catheter 100 and can include a thumb screw 316 for engaging the
catheter to secure the collar in a fixed longitudinal position with
respect thereto. In particular, the set screw 316 can be
selectively positioned such that a tip of the set screw extends
into a central lumen 318 of the collar 314 to engage the
microcatheter 100 disposed therein. As the microcatheter 100 is
advanced distally through the tip protector 300, the collar 314
eventually contacts the proximal end of the tip protector,
preventing further insertion of the catheter. The depth stop 312
can thus be slid along the catheter 100 and locked in place to set
the maximum insertion depth. The catheter 100 can also include
depth markings on the catheter body 102 to help a user place the
depth stop 312 at the desired calculated depth.
In some embodiments, the tip protector can have a standard length
to allow easy depth registration between the tip protector, the
catheter, and the stereotactic system. In some embodiments, the
distal portion of the tip protector is approximately 5 cm in length
and the proximal, increased-diameter portion of the tip protector
is approximately 1 cm in length such that the tip protector has an
overall length of approximately 6 cm. Accordingly, a catheter with
marked depth graduations on its exterior sidewall can be advanced
into the tip protector to the 6 cm marking, indicating that the
distal end of the catheter is aligned (i.e., not protruding or
recessed) with the distal end of the tip protector. Similarly, the
tip protector can be fully-advanced into a stereotactic system
having a 5 cm stem length, such that the distal end of the tip
protector is aligned (i.e., not protruding or recessed) with the
distal end of the stereotactic system.
In some embodiments, the central lumen of the tip protector can
have an inside diameter that corresponds to (e.g., is substantially
equal to or slightly greater than) the outside diameter of the
catheter. For example, the central lumen of the tip protector can
have a diameter of about 0.5 mm to about 4.0 mm. In some
embodiments, the central lumen of the tip protector can have a
diameter of about 1.5 mm. In some embodiments, the central lumen of
the tip protector can have a diameter of about 3.0 mm.
While an exemplary microcatheter 100 and an exemplary stereotactic
system 200 are shown and described above, it will be appreciated
that the tip protector 300 can be sized or otherwise configured to
work with any of a variety of catheters or other small-tipped
devices, and can likewise be sized or otherwise configured to work
with any of a variety of stereotactic systems, stems, collets,
sleeves, frames, etc. In addition, one or more fixtures, adapters,
guides, or other accessories can be included to facilitate use of
the tip protector and/or a microcatheter with a particular
stereotactic system.
Exemplary stereotactic systems include the NAVIGUS system available
from MEDTRONIC, INC. and the VARIOGUIDE system available from
BRAINLAB. Both of these systems are "frameless," meaning they are
mounted directly or close to the patient's head, and do not need
the functional "frame" per conventional stereotactic
procedures.
As shown above and in FIG. 11, the tip protector 300 can be sized
to be received within the inner lumen of the NAVIGUS system 200.
For example, the distal portion 302d of the tip protector 300 can
have a length that is equal to the length of the stem 208, such
that when the tip protector is inserted up to the proximal,
increased-diameter portion 302p, the distal end of the tip
protector is aligned with the distal end or center of the pivoting
stem, which typically serves as the depth reference point in the
system 200. This can advantageously allow for simple depth
registration between the catheter 100, the tip protector 300, and
the system 200. In some embodiments, the distal portion 302d of the
tip protector 300 has a length of approximately 5 cm.
Similarly, as shown in FIG. 12, the length of the tip protector 300
can be selected to correspond with the diameter of the circular
guide block 400 of the VARIOGUIDE system, thereby facilitating
depth registration between the catheter 100, the tip protector 300,
and the system.
In some embodiments, a guide tube can be provided to facilitate
coupling of the tip protector 300 and/or the catheter 100 to the
stereotactic system. FIG. 13 illustrates an exemplary embodiment of
a guide tube 500. As shown, the guide tube 500 has an elongate body
502 with a central lumen 504 extending longitudinally therethrough.
The inside diameter of the central lumen 504 is stepped, such that
the lumen includes an increased-diameter proximal portion 504p
sized to receive the distal end 302d of the tip protector 300 and a
decreased-diameter distal portion 504d sized to snugly receive a
portion of the catheter 100 that protrudes from the distal end of
the tip protector. The guide tube 500 also has a proximal end 502p
with an enlarged outside diameter such that a shoulder 506 is
defined on the exterior of the guide tube. In use, the guide tube
500 can be inserted distally through the guide block of a
stereotactic system until the shoulder 506 engages the guide block.
The tip protector 300 can be inserted into the central lumen 504 of
the guide tube 500 such that the tip protector is supported and
stabilized in the stereotactic system. A lateral opening 508 can be
included in the proximal end of the guide tube 500 to receive a set
screw 510 for locking the tip protector 300 in place within the
central lumen 504. The enlarged proximal end 502p of the guide tube
500 can have a standard length (e.g., 1 cm) to aid in depth
registration. The guide tube 500 can also include a tapered distal
tip 512 for easy insertion of the guide tube into the guide block
of the stereotactic system.
FIG. 14 illustrates an exemplary frame-based stereotactic
system--the CRW frame available from INTEGRA LIFESCIENCES. As
shown, the guide tube 500 can be sized to fit the existing guide
block 602 of the frame 600 and help guide the catheter 100 from the
guide block to the top of the skull 604. For example, the guide
tube 500 can have an outside diameter of 0.25'' to correspond with
the inside diameter of the frame's guide block 602. The guide tube
500 can thus allow the frame 600 to be used with microcatheters 100
that would not otherwise fit in the guide block 602. In some
embodiments, a kit including a plurality of guide tubes having
different lengths can be provided. Accordingly, as the arc of the
frame 600 is moved towards or away from the patient's skull 604
depending on target depth, a guide tube having an appropriate
length can be selected such that the guide tube supports the full
length or a significant portion of the full length of the
microcatheter 100 extending between the guide block 602 and the
skull 604.
FIG. 15 is a schematic illustration of a microcatheter 100 coupled
to a tip protector 300 and depth stop 312 and aligned with the
guide tube 500. FIG. 16 is a schematic illustration of the
microcatheter 100 and tip protector 300 inserted through the guide
tube 500. As shown, the tip protector 300 can be advanced until the
enlarged proximal end 302p of the tip protector engages the
proximal end surface of the guide tube 500.
FIG. 17 illustrates another exemplary frame-based stereotactic
system--the LEKSELL frame available from ELEKTA. As shown, the
system 700 includes an upper guide stop 702 mounted to the arc 704
of the frame. The system 700 also includes a lower guide block 706
mounted to an arm 708 that extends down from the arc 704 towards
the patient's skull 710. In some embodiments, a guide stop adapter
802 and a guide block adapter 804 can be provided to facilitate
coupling of the guide tube 500, tip protector 300, and/or the
catheter 100 to the LEKSELL system 700 or to other similar
systems.
FIG. 18 illustrates a microcatheter 100 (with a depth stop 312 and
a tip protector 300), a guide tube 500, a guide stop adapter 802,
and a guide block adapter 804. These components are illustrated in
an assembled configuration in FIG. 19 and installed in the LEKSELL
frame 700 in FIG. 20.
As shown, the guide stop adapter 802 can be a cylindrical disc
having an inside diameter sized to receive the guide tube 500 and
an outside diameter sized to fit within the guide stop 702 of the
stereotactic system 700. The guide stop adapter 802 can include an
enlarged proximal end 802p that defines an exterior shoulder
806.
The guide block adapter 804 can be a cylindrical sleeve having an
inside diameter sized to receive the guide tube 500 and an outside
diameter sized to fit within the guide block 706 of the
stereotactic system 700. The guide block adapter 804 can include an
enlarged proximal end 804p that defines an exterior shoulder 808.
Lateral openings 810, 812 can be formed in the guide stop adapter
802 and/or the guide block adapter 804 to receive set screws 814,
816 for locking the guide tube 500 in position. In use, the guide
stop adapter 802 and the guide block adapter 804 can be fitted to
the guide stop 702 and guide block 706, respectively, of the
stereotactic frame 700 and adjusted to the desired heights. The
guide tube 500 can then be inserted through the adapters 802, 804,
and can be secured in a fixed longitudinal position by tightening
the set screws 814, 816 of the guide stop adapter 802 and the guide
block adapter 804. The microcatheter 100 and attached tip protector
300 can then be inserted through the guide tube 500. The set screw
of the guide tube 500 can be tightened to secure the tip protector
300 to the guide tube, before or after advancing the microcatheter
100 relative to the tip protector to the desired depth. The set
screw 308 of the tip protector 300 can also be tightened to secure
the microcatheter 100 in a fixed longitudinal position relative to
the tip protector.
It will be appreciated that similar adapters can be made to fit
other frames to facilitate stereotactic use of the tip protectors
and microcatheters disclosed herein. The systems and methods
disclosed herein can facilitate precision-targeted drug delivery
(e.g., via convection-enhanced delivery) using a stereotactic
system and a microcatheter. In an exemplary embodiment, a
stereotactic system is registered to a patient, for example using
MR images. A microcatheter and associated tip protector can be
coupled to the stereotactic system using one or more guide tubes,
guide block adapters, and/or guide stop adapters as disclosed
herein and aimed towards a target site in the patient. The
microcatheter can then be advanced into the patient under
stereotactic guidance until one or more fluid outlet ports of the
microcatheter are positioned at the target site. Drug-containing
fluid can then be infused under positive pressure to deliver the
drug through the catheter to the target site via
convection-enhanced delivery.
The tip protectors, depth stops, fixtures, adapters, guides, and
other components or devices disclosed herein can be manufactured or
produced using any of a variety of techniques, including extrusion,
molding, machining, and combinations thereof. The tip protectors,
depth stops, fixtures, adapters, guides, and other components or
devices disclosed herein can be formed from a variety of materials,
including silastic, poly-urethane, poly-ester, PTFE, E-PTFE,
stainless steel, titanium, polycarbonate, PVC, Delrin, aluminum,
PEEK, plastic, metal, and combinations thereof.
Although the invention has been described by reference to specific
embodiments, it should be understood that numerous changes may be
made within the spirit and scope of the inventive concepts
described. Accordingly, it is intended that the invention not be
limited to the described embodiments, but that it have the full
scope defined by the language of the following claims.
* * * * *